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Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

Primary Purpose

Acute Esophagitis

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ziverel
Sponsored by
Grupo de Investigación Clínica en Oncología Radioterapia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Esophagitis focused on measuring Acute Esophagitis, Radiotherapy, Ziverel, Chondroitin sulfate, Hyaluronic acid, Poloxamer 407, Chemoradiotherapy, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ECOG PS 0-1.
  • Signature of informed consent.
  • Patients with any type of neoplasm that requires treatment with radiotherapy or radiochemotherapy, and who develop a radiation-induced esophagitis of degree ≥ 2 (according to CTCAE v4.03)
  • Hematological function (neutrophils ≥2000 / ml, platelets ≥100000 / ml, hemoglobin> gr / dl), hepatic (bilirubin <1.5) and renal acceptable (glomerular filtration rate> 50 ml / min).
  • Patients without contraindication for the administration of ZIVEREL®, in accordance with the instructions for use of the product.

Exclusion Criteria:

  • ECOGPS≥2
  • Hypersensitivity for some of the active ingredients or a component of ZIVEREL®
  • Alteration in haematological function (neutrophils ≤2000 / ml, platelets ≤100000 / ml, hemoglobin <8gr/dl), hepatic (bilirubin> 1.5) and/or glomerular filtration rate <50 ml/min).
  • Patients who have a medical history of psychiatric disorders or any other condition that interfere with the study
  • Patients with esophageal candidiasis or oral cavity candidiasis at the time of entry into the study.

Sites / Locations

  • Hospital Universitario Ramón y CajalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ziverel arm

Arm Description

Patients included will receive treatment with ZIVEREL®, initially 10 mL every 8 hours, 30 minutes after meals, to avoid physical entrainment by food, during a minimum of 8 weeks, recruited during a period of 12 months. The treatment will be indicated when the patient develops a radiation-induced esophagitis of degree ≥ 2.

Outcomes

Primary Outcome Measures

Symptomatic relief of radiation-induced esophagitis grade ≥2 in cancer patients undergoing radiotherapy and radiochemotherapy after administration of ZIVEREL®.
Symptomatic relief of radiation-induced esophagitis grade ≥2

Secondary Outcome Measures

Dosimetric prognostic factors
Determine the dosimetric prognostic factors in the development of radiation induced esophagitis (Dmed, Dmax, V5, V15, V20, V30, V35, V40, V45, V50, V60)
Analyze the health-related quality of life during the treatment
EORTC QLQ-C30 (version 3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems

Full Information

First Posted
June 26, 2019
Last Updated
July 29, 2021
Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Collaborators
Norgine
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1. Study Identification

Unique Protocol Identification Number
NCT04070677
Brief Title
Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients
Official Title
Prospective, Multicenter Clinical Study Assessing the Effect of ZIVEREL® on the Symptomatic Treatment of Radiation Oesophagitis in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Grupo de Investigación Clínica en Oncología Radioterapia
Collaborators
Norgine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Radiation-induced esophagitis is an acute, dose-limiting toxicity in oncologic treatment. Since it can lead to interruption of treatment, hospitalization, and even death, clinicians should be aware of this condition as an adverse effect of oncologic therapies, in order to prevent interruption of treatment, as it has been associated with reduced survival. ZIVEREL® is a new, over-the-counter medical device that comes as an oral solution in a 10-ml stick pack. It is composed of hyaluronic acid, chondroitin sulfate, and poloxamer 407 and Women plays a role in the symptomatic relief of esophagitis induced by radiotherapy alone or radiochemotherapy in oncologic patients. ZIVEREL® acts naturally and exerts a protective action by reinforcing the effect of the elements that make up the extracellular matrix, where the connective tissue provides the architecture, proteoglycans maintain the fluid-electrolyte balance, and glycoproteins maintain the intracellular substrate responsible for cell-cell reactions and cell-matrix reactions. The objective of this study is to evaluate whether administration of ZIVEREL® diminishes the grade of acute radiation-induced esophagitis and the incidence of severe esophagitis in oncologic patients treated with radiotherapy or radiochemotherapy.
Detailed Description
Hyaluronic acid is a glycosaminoglycan formed by glucuronic acid and N acetylglucosamine disaccharide units. It is found mainly in the extracellular matrix of the loose connective tissue and is associated with several key processes, including cell signaling and repair, as well as with tissue generation, morphogenesis, and structural organization of the extracellular matrix itself. In clinical terms, its role is well known in conditions such as mouth ulcers, where its barrier effect relieves symptoms. Chondroitin sulfate forms part of the glycosaminoglycan group in the extracellular matrix, which is in turn formed by D-glucuronic acid and N-acetylgalactosamine. It has been shown to protect the epithelium of the esophageal mucosa by shielding the epithelial areas damaged by acid, thus diminishing catabolic activity and inhibiting proteolytic enzymes (e.g., metalloproteases, collagenase, or elastase). Chondroitin sulfate also regulates several inflammatory mediators (TNF-α, IL-1β, COX-2, PGE2, and NFκB) and reduces the synthesis of nitric oxide, which is involved in the inflammatory cascade. Polaxamer 407 is a bioadhesive component that acquires the active ingredients of ZIVEREL® adhere to the damaged mucosa and are not dragged away by the ingestion of food and liquids.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Esophagitis
Keywords
Acute Esophagitis, Radiotherapy, Ziverel, Chondroitin sulfate, Hyaluronic acid, Poloxamer 407, Chemoradiotherapy, Chemotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ziverel arm
Arm Type
Experimental
Arm Description
Patients included will receive treatment with ZIVEREL®, initially 10 mL every 8 hours, 30 minutes after meals, to avoid physical entrainment by food, during a minimum of 8 weeks, recruited during a period of 12 months. The treatment will be indicated when the patient develops a radiation-induced esophagitis of degree ≥ 2.
Intervention Type
Combination Product
Intervention Name(s)
Ziverel
Intervention Description
Patients in treatments with radiotherapy alone (RT) or radiochemotherapy (RT-CH) with acute radiation-induced esophagitis grade 2 or superior according to the most recent CTCAE will received support treatment with ZIVEREL®
Primary Outcome Measure Information:
Title
Symptomatic relief of radiation-induced esophagitis grade ≥2 in cancer patients undergoing radiotherapy and radiochemotherapy after administration of ZIVEREL®.
Description
Symptomatic relief of radiation-induced esophagitis grade ≥2
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Dosimetric prognostic factors
Description
Determine the dosimetric prognostic factors in the development of radiation induced esophagitis (Dmed, Dmax, V5, V15, V20, V30, V35, V40, V45, V50, V60)
Time Frame
1 year
Title
Analyze the health-related quality of life during the treatment
Description
EORTC QLQ-C30 (version 3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ECOG PS 0-1. Signature of informed consent. Patients with any type of neoplasm that requires treatment with radiotherapy or radiochemotherapy, and who develop a radiation-induced esophagitis of degree ≥ 2 (according to CTCAE v4.03) Hematological function (neutrophils ≥2000 / ml, platelets ≥100000 / ml, hemoglobin> gr / dl), hepatic (bilirubin <1.5) and renal acceptable (glomerular filtration rate> 50 ml / min). Patients without contraindication for the administration of ZIVEREL®, in accordance with the instructions for use of the product. Exclusion Criteria: ECOGPS≥2 Hypersensitivity for some of the active ingredients or a component of ZIVEREL® Alteration in haematological function (neutrophils ≤2000 / ml, platelets ≤100000 / ml, hemoglobin <8gr/dl), hepatic (bilirubin> 1.5) and/or glomerular filtration rate <50 ml/min). Patients who have a medical history of psychiatric disorders or any other condition that interfere with the study Patients with esophageal candidiasis or oral cavity candidiasis at the time of entry into the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eliseo Carrasco Esteban, MD
Phone
609438605
Ext
0034
Email
eliseo.carrasco.esteban@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fernando López Campos, MD
Email
flcampos@salud.madrid.org
Facility Information:
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando López Campos
Email
flcampos@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Eliseo Carrasco Esteban
First Name & Middle Initial & Last Name & Degree
Fernando López Campos

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study Assessing the Effect of ZIVEREL® in Cancer Patients

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